EN ISO 13408-1:2011
Withdrawn
Withdrawn
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)
Amended by
Published date
06-29-2011
Publisher
Withdrawn date
12-31-2011
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ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.
| Committee |
CEN/TC 204
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| I.S. EN ISO 13408-1:2011 | Equivalent |
| BS EN ISO 13408-1 : 2011 | Equivalent |
| DIN EN ISO 13408-1:2011-09 | Equivalent |
| UNE-EN ISO 13408-1:2011 | Identical |
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